Kornimate/medical-research-clean huggingface dataset:
a clinical trial of tqb3909 tablets in patients with breast cancer

Conditions: Advanced Breast Cancer

Summary: tqb3909 is an inhibitor targeting b-cell lymphoma (bcl)-2 protein. by binding to bcl-2 protein, tqb3909 releases pro apoptotic proteins such as bcl-2-anatagonist/killer 1(bak), bcl-2 associated x (bax) protein and bcl-2 associated death (bad) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3/7 activity and caspase 3/9 cleavage, and induces apoptosis.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. * age: 18 to 75 years old; female patient, an eastern cooperative oncology group (ecog) performance status of 0 to 1. * histopathologically confirmed hr positive and her2 negative advanced or metastatic breast cancer. * patients who have been treated with endocrine therapy and have experienced disease progression. * patients previously treated with any cdk4/6 inhibitor and not treated with bcl-2 inhibitor. * has at least one measurable lesion according to response evaluation criteria in solid tumors (recist) v1.1 criteria * the main organs function well; * female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug. exclusion criteria: * 1. concomitant disease and medical history: 1. there were other malignant tumors in 3 years before the first medication. 2. has multiple factors affecting oral medication; 3. unalleviated toxicity ≥ grade 1 due to any previous therapy; 4. major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study; e．arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; f．have a history of psychotropic drug abuse and can not quit or have mental disorders; g．subjects with any severe and / or uncontrolled disease included: cirrhosis, active hepatitis, history of immunodeficiency; * tumor-related symptoms and treatment: 1. has central nervous system metastases (cns) and/or cancerous meningitis or leptomeningeal carcinomatosis; 2. have received radiotherapy, other antineoplastic therapy within 2 weeks prior to the first dose; 3. has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. * known hypersensitivity to tqb3909, lhrh agonists (e.g., goserelin), or any excipients. * subjects who have received the vaccine within 28 days prior to the first dose, or are planning to receive the vaccine during the study period. * has participated in other clinical trials within 4 weeks before first dose. * according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
health coaching for patients waiting for hip or knee replacements

Conditions: Osteoarthritis, Hip; Osteo Arthritis Knee

Summary: a randomised controlled feasibility study of a health coaching intervention targeting people on the waitlist for hip or knee replacement surgery with low patient activation.

determine the feasibility of recruitment and retention to the trial. evaluate the acceptability of research procedures and outcome measures. explore the impact of trial participation through patient activation, self-reported health outcomes and interviews.

Eligibility criteria:
inclusion criteria: * on the waitlist for total hip or total knee replacement surgery * pam level 1 or 2 exclusion criteria: * current participation in care with a focus on self-management education * pam level 3 or 4
a trial investigating the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male or female, aged 18-65 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 20.0-29.9 kg/m\^2 (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiography and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day) * any blood draw in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening * history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * have personal or family history of myopathy * previous history of muscular toxicity with another hmg-coa reductase inhibitor or fibrate * thyroid-stimulating hormone outside lower limit of normal minus 10 percent and upper limit of normal plus 10 percent * creatine kinase above 5 x upper limit of normal * asian subject
clinical efficacy of silk sericin dressing with collagen for split-thickness skin graft donor site treatment

Conditions: Wound Heal; Wound Surgical; Donor Site Complication

Summary: to examine the efficacy and safety of sericin dressing with collagen in stsg donor site treatment comparing with bactigras®. around 30 patients will be enrolled in this study.

wounds are a public health problem found worldwide that associated with both clinical and economic burdens. although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development. the sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. to evaluate its efficacy and safety, the stsg donor sites of each patient will be divided into two equal areas. each area will be randomly allocated into sericin dressing with collagen group or control group (bactigras®). the outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing bactigras®.

Eligibility criteria:
inclusion criteria: * patients who have stsg donor site wounds on the thigh area * age more than 18 years old * the split-thickness skin graft is harvested for the first time at the investigated area. * patients who are able to communicate with the thai language * willingness to participate exclusion criteria: * patient with a mental disorder or immunocompromised diseases * patients who cannot or not willing to follow the protocol * known sensitivity or allergy to sericin, chlorhexidine, and collagen * pregnancy or lactation

Keywords: wound dressing sericin collagen split-thickness skin graft donor site (stsg donor site)
the efficacy of dexamethasone in combination with n-acetylcysteine in preventing neurocognitive sequelae due to carbon monoxide poisoning

Conditions: Carbon Monoxide Poisoning; Delayed Neurocognitive Sequelae

Summary: background and aim: carbon monoxide (co) poisoning is a significant public health issue that can cause delayed neuropsychological sequelae (dns). dns mechanisms involve oxidative stress, inflammation, and immune injury. although hyperbaric oxygen therapy is widely used, its efficacy in preventing dns remains inconclusive. preclinical and retrospective studies suggest that dexamethasone (anti-inflammatory and immunosuppressive) and n-acetylcysteine (antioxidant) may reduce dns risk. this study hypothesizes that their combination can effectively prevent dns. methods: this prospective pre-post intervention study will enroll co poisoning patients into treatment (dexamethasone + n-acetylcysteine) and control groups. the primary outcome is the incidence of dns within six weeks post-treatment. objective: to determine whether combining dexamethasone and n-acetylcysteine reduces the incidence of dns following co poisoning.


Eligibility criteria:
inclusion criteria: * history and clinical symptoms consistent with co poisoning (initial blood carboxyhemoglobin (cohb) levels \>5%, or \>10% for smokers). exclusion criteria: * concurrent use of other potentially lethal toxins. severe trauma or burns that could be fatal. no spontaneous heartbeat or blood pressure before arrival. poisoning time exceeding 24 hours before hospital arrival. minors (under 18 years of age). pregnant women. patients or their families refuse to sign the consent form. contraindications for the use of dexamethasone or n-acetylcysteine (such as severe allergies) or when the physician assesses the risks outweigh the benefits.

Keywords: carbon monoxide poisoning dexamethasone n-acetylcysteine delayed neurocognitive sequelae
investigation of community reablement on instrumental activities of daily living in people with schizophrenia

Conditions: Schizophrenia

Summary: this is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of reablement-instrumental activities of daily living (re-iadl) on schizophrenia patients at immediately and long-term.

subjects will be randomized to intervention group and control group. the outcome measures include the canadian occupational performance measure, instrumental activities of daily living-3 dimensions, activities of daily living rating scale iii, frenchay activities index, lawton instrumental activities of daily living, mini mental state examination-2nd edition, behavior rating inventory of executive function adult version, allen cognitive level screen-6th, participation measure-3 domains, 4 dimensions, personal and social performance scale, work behavior inventory, schizophrenia-quality of life questionnaire, beck depression inventory-ii, and functioning scale of the disability evaluation system.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia by dsm-5 * age \> 20 years * stable mental symptoms * willing to sign the subject's consent exclusion criteria: * history of severe brain injury * substance abuse * diagnosis of intellectual developmental disorder * unable to follow instructions

Keywords: reablement instrumental activities of daily living
nifedipine xl versus placebo for the treatment of preeclampsia with severe features during induction of labor

Conditions: Preeclampsia Severe

Summary: this is a randomized double blind placebo controlled trial comparing nifedipine 30mg xl to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.

this is a randomized double blind placebo controlled trial comparing nifedipine 30mg xl to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features. after diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. patients were approached about study and if consented then were then randomized to placebo or nifedipine 30xl daily until delivery occurred.

Eligibility criteria:
inclusion criteria: * women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by the american college of obstetricians and gynecologists (acog) criteria. * diagnosis of preeclampsia with severe features with decision made to induce labor. the patient may or may not have already received acute treatment for severe blood pressures. exclusion criteria: * known allergy or adverse reaction to nifedipine or any medical condition where nifedipine is contraindicated, such as galactose intolerance, severe gastrointestinal (gi) structure, and gi hypomotility disorder. * currently receiving nifedipine xl as part of hypertension management prior to induction of labor * participation in another trial that affects the primary outcome without prior approval * physician/provider or patient refusal * participation in this trial in a prior pregnancy * triplet or higher order pregnancy

Keywords: preeclampsia severe, nifedipine 30mg, placebo controlled
efficacy and safety of alirocumab (sar236553/regn727) versus placebo on top of lipid-modifying therapy in patients with high cardiovascular risk and hypercholesterolemia (odyssey combo i)

Conditions: Hypercholesterolemia

Summary: alirocumab (sar236553/regn727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (pcsk9). primary objective of the study: * to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (lmt) in comparison with placebo after 24 weeks of treatment in high cardiovascular (cv) risk participants with hypercholesterolemia secondary objectives: * to evaluate the effect of alirocumab in comparison with placebo on ldl-c at other time points * to evaluate the effect of alirocumab on other lipid parameters * to evaluate the safety and tolerability of alirocumab

the maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.

Eligibility criteria:
inclusion criteria: * participants with hypercholesterolemia and established coronary heart disease (chd) or chd risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin with or without other lmt, both at stable dose for at least 4 weeks to 6 weeks prior to screening (week -2) exclusion criteria: * age \<18 or legal age of adulthood, whichever was greater * participants without established chd or chd risk equivalent * ldl-c \<70 mg/dl (\<1.81 mmol/l) and participants with a history of documented cardiovascular disease * ldl-c \<100 mg/dl (\<2.59 mmol/l) and participants without a history of documented cardiovascular disease * not on a stable dose of lmt (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (week -2) and from screening to randomization * fasting serum triglycerides \> 400 mg/dl (\>4.52 mmol/l) the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
pre-oxygenation with high-flow nasal cannula in adults during rapid sequence induction anesthesia

Conditions: Anesthesia; Hypoxia; Surgery; Acute

Summary: it has been demonstrated that transnasal humidified rapid insufflation ventilatory exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. data from a recent study indicates that transnasal humidified rapid insufflation ventilatory exchange might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. the limitations with our previous study is that it was done only during office hours (mon-friday 8 am to 4 pm) and that the power to detect the occurrence of desaturation was too low. based on the above, the aim is now to conduct a clinical international multicenter study 24/7 with 450 patients and with a simplified protocol that allows the study to be done 24/7. this study is done with the aim of evaluation before implementing this novel technique of preoxygenation into clinical practice. the general purpose of this project is to compare a the preoxygenation technique based on transnasal humidified rapid insufflation ventilatory exchange with traditional preoxygenation with a tight fitting mask during rapid sequence induction (rsi) intubation in patients undergoing emergency surgery.


Eligibility criteria:
inclusion criteria: 1. adult, \>18 years old 2. emergency intubation where rapid sequence induction is indicated 3. capable of understanding the study information and signing the written consent. exclusion criteria: 1. body mass index \>35 2. pregnancy 3. dependency on non-invasive ventilation to maintain oxygen saturation
social prescribing and relationship cognitive strategies (sparcs)

Conditions: Social Isolation; Suicidal Ideation

Summary: the study team is testing the acceptability and feasibility of two treatments for improving loneliness: social prescribing and brief cognitive therapy. for this pilot study, the study team have adapted these treatments for collaborative care and are studying whether these are practical and well-received by patients that might use them.

the study will take place at 2 university of michigan sites.

Eligibility criteria:
inclusion criteria: * screen positive for either or both of the following during routine clinic screening: * social isolation in the past 6 months, according to the screening question "how often do you feel isolated from others?" * suicidal ideation in the past 12 months, according to the 9th item of the patient health questionnaire (hq-9) (per protocol) * loneliness, according to the 3-item version of the university of california, los angeles (ucla) loneliness scale (per protocol) * are currently receiving or are able to initiate collaborative care management at to participant's study site exclusion criteria: * currently receiving or have an active referral for specialty mental health or substance use disorder treatment outside of primary care * neurocognitively impaired according to chart diagnosis, self-report on the eligibility screening survey, or inability to answer comprehension check questions during the informed consent process (per protocol) * unable to participate in the interventions and research assessments due to planned travel or limited phone access (e.g., does not own phone) * terminally ill or receiving of palliative care with less than 6 months life expectancy

Keywords: collaborative care management social prescribing relationship cognitive strategies
clinical evaluation of the aptima® combo 2® assay using the panther® system in female urine samples

Conditions: Chlamydia Trachomatis; Gonorrhea

Summary: the objective of this study is to evaluate the performance characteristics of the ac2 assay on the panther system using female urine specimens.


Eligibility criteria:
inclusion criteria: * the subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months). * for subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (irb). * the subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and: * reports symptoms consistent with a suspected sti (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or * is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected sti; or * is asymptomatic and undergoing screening evaluation for possible stis; or * is asymptomatic and undergoing a routine pelvic examination. exclusion criteria: * the subject took antibiotic medications within the last 21 days prior to collection. * the subject already participated in the study. * the subject has a history of illness that the pi or designee considers could interfere with or affect the conduct, results, and/or completion of the study.
emergency department management of tobacco use disorder

Conditions: Tobacco Use Disorder; Tobacco Use Cessation

Summary: the objective of this study is to determine the effectiveness of ed initiated nrt on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.


Eligibility criteria:
inclusion criteria: * current daily use cigarettes greater than or equal to ½ pack per day * stable for discharge from the ed * able and willing to complete telephone/electronic follow up at scheduled intervals * reported english speaking exclusion criteria: * patients enrolled in specific health insurance plans (peia, the health plan or medicaid medical insurance) * wvu students * medically unstable patients * patients with clinical decompensation or who are admitted to the hospital * patients who are discharged to residential treatment facilities for detoxification * uncontrolled psychiatric disorder or psychiatric emergency * individuals who are unable to provide consent * incarcerated individuals * language barrier * currently pregnant or attempting to become pregnant * presenting for evaluation of sexual assault * known allergy or previous intolerance to nicotine replacement therapy
paceport swan-ganz data collection study

Conditions: RV Dysfunction

Summary: in association with edwards lifesciences, the study will aim to develop an algorithm based on right heart (right atrial, right ventricular and pulmonary artery) waveforms for the early detection of rv dysfunction in cardiothoracic and liver surgery patients at ummc. this is a prospective, non-interventional, observational study.


Eligibility criteria:
inclusion criteria: 1. be ≥ 18 years of age presenting to the university of minnesota medical center undergoing any cardiac surgery with cardiopulmonary bypass (cpb) or liver transplantation 2. participate in the informed consent process and sign/date the approved informed consent forms 3. projected to receive swan-ganz paceport catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (svo2) measures exclusion criteria: 1. patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein 2. patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a tee is contraindicated 3. patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm 4. patients unable to consent to participating in the study 5. patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery 6. patients under the age of 18 years old 7. patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy 8. patients allergic to fore-sight elite sensor adhesive 9. patients with latex allergy due to presence of latex in the swan-ganz catheter balloon.